CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
FDA premarket approval P900060/S037 · decided 2006-11-03
Approval details
- PMA number
- P900060
- Supplement
- S037
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Corcym S.r.l.
- Date received
- 2006-10-10
- Decision date
- 2006-11-03
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT SORIN BIOMEDICA CARDIO S.R.L., SALUGGIA (VERCELLI), ITALY.
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